OK Gütesiegel

Travellers to Switzerland might wonder about the bright pink OK on virtually every condom packaging. Even more irritating is the fact that the normally familiar Durex packaging (from home) are marked the same way.

Now what is it?

It’s the Swiss quality seal to ensure the highest quality for condoms in the Swiss market. It confirms that they have been tested thoroughly before they were released for sale.

What’s the Guetesiegel all about?

Condoms with the Quality Seal are guaranteed to meet European Standard for condoms (EN ISO 4074). In addition they must meet the more stringent requirements of the Swiss Association for the Condom Quality Seal. Each individual unit of production (lot, batch) of condoms with the Quality Seal must be tested by an independent laboratory before being released for sale.

The kitemark is not mandatory, but the Swiss are so used to the pink condom that they check for it first thing when grabbing a pack of condoms.

What should interested companies do to obtain the OK Guetesiegel?

The Verein Gütesiegel für Präservative (Association for the Condom Quality Seal) awards the ok-Quality Seal to all firms that make a contractual undertaking to sell in Switzerland only those condoms that meet the requirements of the Association. The Association concludes a contract with any interested firm, in which, among other things, a high standard penalty is agreed in the event of the firm’s failure to meet the Association’s standard of quality.

Here’s a short overview why the OK are safer than other standards:

Producers, packing agents or importers may use the Quality Seal for Condoms if they agree by contract to
fulfil all parts of the Regulations relating to the Quality Seal for Condoms.

Condoms must conform to the Swiss Ordinance on Medical Devices (MepV)

Each batch must be tested by an independent laboratory before released for sale (lot-by-lot testing). A burst test and a freedom from holes test must be carried out.

The arithmetical mean of the bursting volume of the random sample tested must be at least 28 litres. A
batch is passed if, for an AQL of 1.0, the burst volume of the individual test is at least 75% of the
arithmetic mean of the bursting volume of the batch and if the bursting pressure for the individual test is
over 1.0 kPa.

The requirements of EN ISO 4074 apply to the test on freedom from holes for natural rubber latex
condoms.

Procedure: A random sample will normally be taken from a completed batch by an agent of the Verein Gütesiegel für
Präservative (Quality Seal for Condoms Association) and tested at an accredited laboratory, the
accreditation of which must be recognised by the EA, the European Co-operation for Accreditation. In a
separate contract relating to the use of the Quality Seal, the User of the Quality Seal undertakes to sell
only tested batches on the Swiss market.

The Association ensures that the Regulations are observed by taking market samples. Analysis of the test
results is carried out in accordance with the Appendix of 30 March 2004.

Everyone looking for deeper insights please visit the assosiations website and find their pdf’s under Regulations.